Madison Area Lyme Support Group

Last Friday, the Centers for Disease Control (CDC) released a report which is adding fuel to the fire in the debate about the existence, and treatment, of “chronic Lyme Disease.”

CDC Morbidity and Mortality Weekly report, “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease,” states that “chronic Lyme disease” is not a scientifically verifiable illness, and that treatments of prolonged antibiotic therapy are ineffective at best, and at worst, potentially fatal.

“Clinicians, health departments, and patients have contacted CDC with reports of serious bacterial infections resulting from treatment of persons who have received a diagnosis of chronic Lyme disease,” the report states.

The study highlights case histories of five patients who were treated for chronic Lyme disease with long-term antibiotics. Complications included septic shock, Clostridium difficile colitis, osteodiscitis, abscess, and in two cases, death.

“These cases highlight the severity and scope of adverse effects that can be caused by the use of unproven treatments for chronic Lyme disease,” the report states. “In addition to the dangers associated with inappropriate antibiotic use, such as selection of antibiotic-resistant bacteria, these treatments can lead to injuries related to unnecessary procedures … and missed opportunities to diagnose and treat the actual underlying cause of the patient’s symptoms.”

Patients in the study were treated with intravenous antibiotics with a PICC (peripherally inserted central catheter). The surgically inserted line injects the antibiotic directly into the bloodstream on the theory that oral antibiotics don’t work as well because they don’t break the blood-brain barrier. The new study took a dim view of PICCs, stating that they were consistently a source of infection.

Regarding the scope of the three-year study, a CDC spokesperson told The Times in an email, “CDC has periodically heard from state health departments and clinicians about patients who have acquired serious bacterial infections during treatments for what is sometimes referred to as ‘chronic Lyme disease.’ We have heard of many cases, but limited the report to five examples.”

Test questioned

The blood tests currently used to detect the presence of Borrelia burgdorferi bacteria, which cause Lyme disease, are the enzyme-linked immunosorbent assay (ELISA), and the Western blot test, which can confirm the results of an ELISA test.

Chronic Lyme disease advocates believe that current testing methods are inaccurate, and a major source of their concern. Last week’s CDC report also addresses this: “There is a belief among persons who support the diagnosis and treatment of chronic Lyme disease that Borrelia burgdorferi can cause disabling symptoms even when standard testing is negative, despite evidence that the recommended two-tiered serologic testing is actually more sensitive the longer Borrelia burgdorferi infection has been present. Some practitioners use tests or testing criteria that have not been validated for the diagnosis of Lyme disease. A significant concern is that after the diagnosis of chronic Lyme disease is made, the actual cause of a patient’s symptoms might remain undiagnosed and untreated.”

According to a CDC spokesperson, “You may have heard that the blood test for Lyme disease is correctly positive only 65 percent of the time or less — this is misleading information. As with serologic tests for other infectious diseases, the accuracy of the test depends upon the stage of disease. During the first few weeks of infection, the test is expected to be negative. Several weeks after infection, currently available two-tier testing has very good sensitivity … Antibodies against Lyme disease bacteria usually take a few weeks to develop, so tests performed before this time may be negative even if the person is infected. It is not until 4 to 6 weeks have passed that the test is likely to be positive. This does not mean that the test is bad, only that it needs to be used correctly.”  (Please see comment at end of article)

Sam Telford, an expert on tick-borne diseases and professor of infectious disease and global health at Tufts University, former MV Times columnist, and chronic Lyme disease skeptic, told The Times that the new CDC report is “yet more evidence” that people should question a chronic Lyme disease diagnosis if the traditional tests show no trace of Borrelia burgdorferi. “When the evidence for a diagnosis rests on testing by a handful of specialty laboratories, in the face of evidence from well-validated tests that have been in use for 30 years, it seems to me that they are limiting their chances for a different diagnosis and treatment to improve life … I think that to the detriment of their health, some people with true illness embrace a faith-based diagnosis instead of an evidence-based [scientific] diagnosis. The CDC report shows what can happen … very tragic. There are many possible diagnoses for the signs and symptoms experienced by those who undergo such extreme treatment regimens.”

Theories behind lingering Lyme

Most people infected with Lyme disease are cured with a two- to four-week regimen of strong antibiotics, most often doxycycline. However, roughly 10 percent of those infected experience long-term symptoms that include muscle ache, joint pain, fevers, cognitive impairment, and extreme fatigue.  (See comment at end of article)

The Centers for Disease Control (CDC) calls this condition post-treatment Lyme disease syndrome (PTLDS), and unlike chronic Lyme disease, the industry-standard blood tests confirm the presence of the Borrelia burgdorferi bacterium.

“The good news is that patients with PTLDS almost always get better with time; the bad news is that it can take months to feel completely well,” the CDC website states. The CDC does not recommend use of long-term antibiotics for PTLDS. “Regardless of the cause of PTLDS, studies have not shown that patients who received prolonged courses of antibiotics do better in the long run than patients treated with placebo.”

There is a growing faction that believes chronic Lyme disease exists irrespective of CDC studies, and that people presenting with persistent Lyme disease symptoms should be treated with long-term antibiotics.

On a visit to Martha’s Vineyard Hospital last summer, Dr. Nevena Zubcevik, attending physician at Harvard Medical School and co-director of Dean Center for Tick Borne Illness at Spaulding Rehabilitation Hospital in Charlestown, said she believes the current testing methods are inadequate.

She cited information from a researcher at the CDC: “Barbara Johnson, an expert with the CDC Lyme program, reveals that the current two-tier method is positive in only 31 percent of those with erythema migrans (the bull’s-eye rash associated with Lyme disease) and in only 63 percent of those with acute neuroborreliosis or carditis due to Lyme disease. This means that out of 100 patients who have Lyme disease, we might misdiagnose 69 of them, leaving their infections untreated … Given the current urgent state of affairs, we should be racing to find better testing strategies that will identify all of the Borrelia species and associated co-infections, and to find better antibiotic regimens that will cure our patients.”

Dr. Zubcevik suggested that the correct antibiotics aren’t being used to treat the long-term symptoms of Lyme disease. She diagnoses this condition as “persistent symptoms related to Lyme disease,” not chronic Lyme disease. “The drugs we are using might be contributing to persistent bacteria, and may not be fully clearing infections,” she wrote in an email to The Times last year.

Dr. Zubcevik did not respond to The Times’ request for comment on the new study.

Though her stance is controversial, it resonated on Beacon Hill. Last July, the House of Representatives, overriding Governor Baker’s veto, passed a bill requiring health insurance providers to cover the cost of long-term antibiotics. Massachusetts was also one of the first states to enact a bill protecting doctors who prescribed long-term antibiotics, when Governor Deval Patrick signed it into law in June 2011.

Enid Haller works as a patient advocate at the Dean Lyme Center, where a number of Vineyarders, and people from all over the country, go for treatment. Ms. Haller also runs the Lyme Center of Martha’s Vineyard, described on her website as a walk-in information service for Lyme and tick-borne diseases, on Panhandle Road in West Tisbury.

Ms. Haller told The Times she believes the CDC, and Mr. Telford, are wrong about the accuracy of the ELISA and Western blot tests. She said she suffered the long-term effects of Lyme disease for more than 10 years, and never tested positive for Lyme disease with the traditional tests given at Martha’s Vineyard Hospital. “The Igenex test is essentially a better implemented Western blot test,” she said. “I came back very positive for Lyme [disease] with the Igenex test.” Ms Haller said the Igenex test should be the standard test for the Cape and Islands, including Martha’s Vineyard Hospital. She said the Dean Lyme Center at Spaulding Hospital in Charlestown uses the Igenex test, and her treatment there has been the breakthrough she’d sought for more than a decade. She said getting the antibiotics intravenously, through a PICC line, was the key.

“It worked incredibly well,” she said. “I had my PICC line removed last November because you have to take it out after a year, because the tubing starts to deteriorate. After the holidays, the symptoms slowly started to come back, the joint pain, the brain fog; I had trouble walking. But a month ago I had a PICC line put back in, and I started feeling better in 48 hours. The pressure in my head just went away.”

Ms. Haller said she feels well enough to join four other Spaulding patients who are traveling to Germany in three weeks for “hyperthermia treatment,” a process where the body temperature is raised enough to kill Borrelia burgdorferi. “I’ve spoken to a lot of people who’ve gotten better from it. I know I can’t be on antibiotics forever,” she said.

Conspiracy theorized

Ms. Haller said she thinks last week’s release of the CDC report was in response to an “uprising,” spearheaded by four people from Lyme Cryme, a chronic Lyme Disease advocacy group, who traveled to Washington, D.C., two weeks ago to lobby congressmen. Lyme Cryme members allege that there has been a coverup orchestrated by the CDC, and that the agency has long advocated ELISA and Western blot tests, knowing that they don’t work. “They’re starting a class-action lawsuit against the CDC, so it doesn’t surprise me the CDC came out with the article last week,” Ms. Haller said.

A 249-page treatise by the $ociety for the Advancement of $cientific Hermeneutics ($A$H), titled “Descrambling the Centers for Disease Control and Prevention’s (CDC’s) For-Profit scientific nonsense,” also alleges CDC perfidy, with an underlying profit motive. “We don’t test positive on the stupid test because it was designed to fail. It was designed to market a vaccine, not diagnose Lyme disease. A core group of doctors with financial interests in the Lymerix vaccine have intentionally misled the medical community about them … At some point, it was decided by CDC officers that they should commercialize Lyme and other emerging tick-borne diseases by patenting vaccines and test kits … Their plan: Make Lyme only 15 percent detectable so that the Cabal would be guaranteed to have an at least 85 percent ‘effective’ vaccine. If they maliciously discredited the people who became ill as a result of the ‘vaccine’ itself (septic shock) or vaccine failure (Lyme), then the vaccine would be ‘safe,’ too. We call both the crime of falsifying the testing and the resultant — and current — bogus testing criteria, ‘Dearborn.’”

Ms. Haller alleged Mr. Telford is also involved in the deception. “Sam owns part of the vaccine,” she said. “Whenever he speaks on the Vineyard, he’s always pushing the vaccine. I always wondered why. I would be interested to know the other doctors who own the vaccine, because they stand to make a lot of money. This is getting exposed now, and I think that’s why Sam gets so mad when we discuss this.”

Ms. Haller said she knows people who have gotten sick from Lymerix, which was introduced in 1998 and withdrawn three years later amid a class-action lawsuit alleging it caused arthritis-like symptoms. “I know people who have dementia because of the Lymerix vaccine, and Sam refuses to acknowledge that. The veterinarians use it, but I know many people on the Vineyard who have given it to their dogs or cats or horses, and they have terrible reactions to the vaccine. They’re probably still making millions and millions of dollars from that.”

In an email to The Times, Mr. Telford dismissed the CDC conspiracy as “ravings,” and stated he has no financial interest or motives with Lymerix. “In 1991, I co-discovered the mode of action of the vaccine … that is all. I did not make the vaccine. I own no patents, never did, received no funding other than to help run the Phase II clinical trial back in the mid-1990s, receive no funding now, and am not pushing it for any financial gain. I hope to revive Lymerix under a nonprofit structure … vaccines for the people by the people. I am pushing for this because I am outraged that Lyme incidence keeps going up and up, and something I helped develop as a younger scientist might have prevented hundreds of thousands of cases over the past decade … and could do so in the decade to come.”

Prevention remains the key

Prevention is paramount when it comes to fighting the spread of Lyme disease and other virulent tick-borne diseases — babesiosis, spotted fever, Rocky Mountain spotted fever, tularemia, Powassan virus, and ehrlichiosis — by wearing permethrin-treated clothes when working or playing outdoors, and making daily tick checks.

This is especially crucial in the months May through early July, when the vast majority of infections will take place.

More information on tick-borne disease prevention can be found on the Martha’s Vineyard Boards of Health Tick-Borne Disease webpage.